A Phase III, Multi-center Study to Evaluate the Safety and Efficacy of Epithelium-on Corneal Collagen Cross-linking in Eyes With Progressive Keratoconus
Phase of Trial: Phase III
Latest Information Update: 18 Jan 2019
At a glance
- Drugs Riboflavin (Primary)
- Indications Keratoconus
- Focus Registrational; Therapeutic Use
- Sponsors Avedro
- 05 Apr 2018 Status changed from not yet recruiting to recruiting.
- 15 Mar 2018 According to an Avedro media release, if trial objectives met this study would form the primary basis of a regulatory submission to obtain FDA approval of Avedros epi-on cross-linking treatment.
- 15 Mar 2018 According to an Avedro media release, the company has reached agreement with the U.S. Food and Drug Administration (FDA) regarding a Special Protocol Assessment (SPA).